Total submissions: 6
Submitter | RCV | SCV | Clinical significance | Condition | Last evaluated | Review status | Method | Comment |
---|---|---|---|---|---|---|---|---|
Clin |
RCV000631090 | SCV001371700 | uncertain significance | Glycogen storage disease, type II | 2023-04-06 | reviewed by expert panel | curation | The NM_000152.5:c.1288G>A (p.Glu430Lys) variant in GAA has a highest population minor allele frequency in gnomAD v2.1.1 of 0.00043 (10/23086 alleles) in the African population, which is lower than the ClinGen Lysosomal Diseases VCEP’s threshold for PM2_Supporting (<0.001), meeting this criterion (PM2_Supporting). The computational predictor REVEL gives a score of 0.577 which is neither above nor below the thresholds predicting a damaging (>0.7) or benign (<0.5) impact on GAA function. SpliceAI predicts no impact on splicing. To our knowledge, this variant has not been reported in the literature in individuals with Pompe disease, and the results of functional studies are not available. However, there is a ClinVar entry for this variant (Variation ID: 501777). In summary, this variant meets the criteria to be classified as a variant of uncertain significance for Pompe disease. GAA-specific ACMG/AMP criteria applied, as specified by the ClinGen Lysosomal Diseases VCEP (Specifications Version 2.0): PM2_Supporting. (Classification approved by the ClinGen Lysosomal Diseases Variant Curation Expert Panel, April 6, 2023) |
Eurofins Ntd Llc |
RCV000597568 | SCV000708268 | uncertain significance | not provided | 2017-05-02 | criteria provided, single submitter | clinical testing | |
Labcorp Genetics |
RCV000631090 | SCV000752083 | uncertain significance | Glycogen storage disease, type II | 2022-08-20 | criteria provided, single submitter | clinical testing | This sequence change replaces glutamic acid, which is acidic and polar, with lysine, which is basic and polar, at codon 430 of the GAA protein (p.Glu430Lys). This variant is present in population databases (rs375433002, gnomAD 0.04%). This variant has not been reported in the literature in individuals affected with GAA-related conditions. ClinVar contains an entry for this variant (Variation ID: 501777). Advanced modeling of protein sequence and biophysical properties (such as structural, functional, and spatial information, amino acid conservation, physicochemical variation, residue mobility, and thermodynamic stability) performed at Invitae indicates that this missense variant is not expected to disrupt GAA protein function. In summary, the available evidence is currently insufficient to determine the role of this variant in disease. Therefore, it has been classified as a Variant of Uncertain Significance. |
Fulgent Genetics, |
RCV000631090 | SCV002816262 | uncertain significance | Glycogen storage disease, type II | 2021-09-07 | criteria provided, single submitter | clinical testing | |
Revvity Omics, |
RCV000597568 | SCV003810581 | uncertain significance | not provided | 2022-05-05 | criteria provided, single submitter | clinical testing | |
Natera, |
RCV000631090 | SCV002092007 | uncertain significance | Glycogen storage disease, type II | 2021-01-06 | no assertion criteria provided | clinical testing |